Material for PUW used to cleaning

ifserav

Quite Involved in Discussions
#1
Dear all
We are going to build a medical device, in this process we are going to clean some pieces with PUW. Does this system have to satisfy all requirements from FDA?, Does CPVC can be used ?, in case of yes, does CPVC has to have a certificate?

The medical device is final stirilized
Thanks in advance.

Sergio Avila
 

Ronen E

Just a person
Super Moderator
#2
Does this system have to satisfy all requirements from FDA?
Yes, if that device is to be distributed for use in the USA. The real interesting question is what are the actually applicable FDA requirements. As a minimum I would say process validation for the PUW system, to ensure you always get out of it what you expect to get. Additionally you’d probably need to run a cleaning validation on your device cleaning process.

Does CPVC can be used?
Why not? What are your concerns?

does CPVC has to have a certificate?
In a system like that it’s always recommended to establish confidence regarding critical components’ make up.
 
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